Recruiting

Phase 2

PF-07328948A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)

Sponsor:

Pfizer

Code:

NCT06991257

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

Low Dose PF-07328948

Medium Dose PF-07328948

High Dose PF-07328948

Study Details

Brief summary:

The purpose of this study is to learn about the safety and effects of the study medicine (PF-07328948) for the possible treatment of heart failure (HF).

Conditions

Heart Failure

Study ID

NCT06991257

Start date

Jun 19, 2025

Status verified date

May, 2026

Completion date

Dec 14, 2027

Anticipated

Primary completion date

Nov 16, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

This study is seeking participants who are:

Key Inclusion Criteria include:

aged 18 years to < 80 years
clinically confirmed to have a diagnosis of heart failure for at least 3 months
New York Heart Association Class II-IV symptoms
left ventricular ejection fraction greater than 40%
Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score < 85
Six-minute walking distance greater than 75 meters

Key Exclusion Criteria include:

Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body.
Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctor.
History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes
Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor

Study Design

Enrollment

620 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: ARM 1

Placebo Participants will receive Placebo for up to 36 weeks

experimental: ARM 2

Low dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

experimental: ARM 3

Medium dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

experimental: ARM 4

High dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Interventions

Placebo

ARM 1

Low Dose PF-07328948

ARM 2

Medium Dose PF-07328948

ARM 3

High Dose PF-07328948

ARM 4

Primary outcome measure

Number of Participants with Clinical Events [ Time Frame: over 36 weeks ]
Change From Baseline in 6-Minute Walk Test (6MWD) [ Time Frame: Baseline, week 36 post-dose ]
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS) [ Time Frame: Baseline, week 36 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

National Heart Institute

Recruiting

Beverly Hills, California, United States, 90211

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Comprehensive Cardiovascular Care

Recruiting

Santa Maria, California, United States, 93454

FOMAT Medical Research

Recruiting

Santa Maria, California, United States, 93454

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Infinite Clinical Research

Recruiting

Miami, Florida, United States, 33133

Flourish Research Acquisition, LLC dba Flourish Research - North Miami

Recruiting

Miami, Florida, United States, 33138

Amavita Research Services

Recruiting

North Miami Beach, Florida, United States, 33169

Clinical Site Partners, LLC dba Flourish Research

Recruiting

Winter Park, Florida, United States, 32789

NMH Clinical Research Unit

Recruiting